# K071308: Modification to Neuviz Dual Multi-Slice CT Scanner System

- Pathway: 510(k) (Traditional)
- Applicant: Neusoft Medical Systems Co., Ltd.
- Decided: Aug 16, 2007 after 99 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062451: Neuviz Dual Multi-Slice CT Scanner System, Neusoft Medical Systems Co., Ltd. (2006) Summary page 3.
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 3.

## Most influential descendants
- K080540: Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 (2008), 0 descendants of its own

## Recalls of this device
- Mar 4, 2013 · Class II · Z-1166-2013: User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another pe
- Oct 18, 2012 · Class II · Z-0466-2013: The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
- Feb 10, 2010 · Not classified · Z-0846-2011: Potential for the CT patient table top to become detached from the carrier due to missing washers.
- Jul 21, 2008 · Not classified · Z-2237-2010: The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.
- Jun 23, 2008 · Not classified · Z-2307-2008: Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the i
- Apr 10, 2008 · Not classified · Z-0001-2009: An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria
- Dec 17, 2007 · Not classified · Z-2235-2008: Labeling of patient position on scanned image does not match actual patient orientation.

## Indications for use
The NeuViz Dual Systems (modified) are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

Source page: https://510kreport.com/device/K071308
Methodology: https://510kreport.com/methodology